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FDA 510(k)

Lapidus Screw Kit

K-Number: K262075 · 2026-07-22

ApplicantRelja Innovations, LLC
Decision Date2026-07-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lapidus Screw Kit is the device name listed in this FDA 510(k) record. The listed applicant is Relja Innovations, LLC. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262075. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lapidus Screw Kit?

Lapidus Screw Kit is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Relja Innovations, LLC. The 510(k) number is K262075.

When did Lapidus Screw Kit receive FDA 510(k) clearance?

Lapidus Screw Kit received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262075.

Who is the listed applicant for Lapidus Screw Kit?

The FDA 510(k) record lists Relja Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lapidus Screw Kit?

The FDA product code for Lapidus Screw Kit is HWC. This falls under the Cardiovascular category.

Other records listing Relja Innovations, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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